電子煙質(zhì)量標準

1、Research & DevelopmentQuality AssuranceElectronic Cigarette Quality Policy and Procedures電子煙質(zhì)量方針和規(guī)程July 1st, 電子煙質(zhì)量標準第1頁Electronic Cigarette Quality Policies and Procedures Copyright JTI JTI Quality Guideline Contents JTI質(zhì)量指導標準內(nèi)容21.GENERAL INFORMATION基本信息1.1Introduction介紹1.2JTI Quality Policy質(zhì)量方針2.QU

2、ALITY STANDARDS質(zhì)量標準2.1General instructions基本指導2.2Physical Quality Criteria物理質(zhì)量標準2.3Chemical Quality Criteria化學質(zhì)量標準2.4Electrical Quality Criteria電子質(zhì)量標準2.5Functional Quality Criteria功效質(zhì)量標準2.6Visual Quality Criteria外觀質(zhì)量標準3.PRODUCT DEVELOPMENT & LAUNCH產(chǎn)品開發(fā)和導入3.1General Instructions for Specifications規(guī)格基

3、本要求3.2Specification Change Process規(guī)格變更流程4.PRODUCT MAINTENANCE產(chǎn)品維護4.1Incoming Material Inspection & Defect Management來料檢驗和不良管理4.2Supplier Qualification and evaluation供給商資格和評定4.3Shelf Life Policy保質(zhì)期政策5.PRODUCT MONITORING產(chǎn)品監(jiān)控5.1Finished Goods Inspection成品檢驗5.2Sample submission to JTI提交給JTI樣品5.3Sample S

4、hipping Instructions樣品運輸要求5.4Quality Measuring Equipment and Methods質(zhì)量檢驗設(shè)備和方法6.PROCESS CONTROL過程控制6.1Change Over Procedure換線程序6.2Manufacturing Quality Plan制造質(zhì)量計劃6.3QUIP ProcedureQUIP程序7.QUALITY MANAGEMENT質(zhì)量管理7.1Hygiene management衛(wèi)生管理7.2Consumer/Customer Complaint Handling Procedure消費者/客戶投訴處理程序7.3Ser

5、ious Quality Incident Management嚴重質(zhì)量事故管理7.4Traceability追溯性7.5Training 培訓電子煙質(zhì)量標準第2頁Electronic Cigarette Quality Policies and Procedures3 Copyright JTI 1. GENERAL INFORMATION基本信息Background 背景Manufacture of E-Cigarettes and tank products will be in 3rd party factories電子煙和霧化器將在第三方工廠生產(chǎn)JTI quality require

6、ments need to be clearly communicated in order to meet consumer and regulatory requirements 要將JTI質(zhì)量要求溝通清楚，以到達消費者和法規(guī)要求Objective目標Introduce and align quality parameters/procedures介紹質(zhì)量參數(shù)和程序并與供給商達成一致Production of a clear and concise reference document on JTI Quality Policies and Procedures for use by 3r

7、d party manufacturers第三方制造商了解并執(zhí)行清楚簡明JTI質(zhì)量方針和程序Quality Policy and Procedures質(zhì)量方針和程序3電子煙質(zhì)量標準第3頁Electronic Cigarette Quality Policies and Procedures4 Copyright JTI Purpose目標Clearly understood essential quality parameters for JTI products明白JTI質(zhì)量參數(shù)Acceptable Quality Limit for defects detected during lot

8、inspection不良可接收程度樣品Applicable to finished product適合用于成品Parameters concerned with the critical quality characteristics of the product關(guān)鍵參數(shù)Examples:Physical, chemical, electrical, functional and visual criteria物理，化學，電子，功效和外觀標準42. QUALITY STANDARDS質(zhì)量標準PhysicalChemicalElectricalFunctionalVisualLength長度Di

9、ameter直徑E-Liquid weight煙液重量Chemical components of vapor 化學成份Cartomizer resistance煙彈阻值Battery capacity電池容量Device activation on puffing能夠出煙LED lightingLED亮燈Chargeability可充電Cracks/scratches劃痕Peeling stickers標簽脫落E-liquid leakage漏液電子煙質(zhì)量標準第4頁Electronic Cigarette Quality Policies and Procedures Copyright J

10、TI All defects/deviations are assigned a defect code.不良有不良代碼A Defect: Defect is not too obvious to consumer (defect not easily noticed by consumer & consumer perception of JTI product quality not affected)A類不良：不良不輕易被發(fā)覺B Defect:Defect may damage JTI brand image (defect is easily noticed by consumer &

11、 consumer perception of JTI product quality is slightly affected)B類不良：不良會輕微影響JTI品牌形象，不良輕易就被消費者發(fā)覺C Defect:Defect damages JTI brand image (defect is clearly noticed by consumer & consumer perception of JTI product quality is negatively impacted)C類不良：不良會給JTI品牌形象造成負面影響，不良輕易就被消費者發(fā)覺D Defect: Defect may se

12、riously damage JTI brand image (defect is the most critical & consumer perception of JTI product quality is seriously impacted); these products are not to be shipped to marketD類不良：嚴重影響JTI品牌形象，產(chǎn)品不能出貨Physical, chemical, electrical, functional and visual criteria52. QUALITY STANDARDS電子煙質(zhì)量標準第5頁Electroni

13、c Cigarette Quality Policies and Procedures Copyright JTI AQL is defined in ISO 2859-1: Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection.使用ISO2859-1It is the maximum tolerable process average of % defects ob

14、served.是最大允許不良數(shù)An AQL of 0.65 is set for B and C class defects combined, and an AQL of 0.15 is set for C class defects. 0.65適合用于B，C類加起來不良，0.15適合用于C類不良A class defects are regarded for process quality improvement.A類不良需要品質(zhì)提升D class defects are not tolerated at any level.D類不良不允許Examples of D Class defec

15、ts:比如Wrong material 錯料Missing products/components少料，少零件E-liquid contamination 煙液污染Acceptable Quality Limit (AQL) 62. QUALITY STANDARDS電子煙質(zhì)量標準第6頁Electronic Cigarette Quality Policies and Procedures Copyright JTI Specifications define all recognizable and measurable factors required to manufacture a p

16、roduct. They cover: 規(guī)格要求了全部生產(chǎn)產(chǎn)品需要要素Material specifications原材料規(guī)格Product specifications 產(chǎn)品規(guī)格Process specifications 過程參數(shù)Specifications are defined by specification owner and cannot be modified by the manufacturer without appropriate authorisation.規(guī)格是產(chǎn)品全部者制訂，制造商沒有授權(quán)不得修改E-cigarette manufacturer is respon

17、sible for maintaining the factory specification system, ensuring product is manufactured according to specification and reporting any deviations to the specification owner and JTI R&D QA. 按照規(guī)格生產(chǎn)，有任何差異需要向JTI R&D品質(zhì)匯報Specification control73. PRODUCT DEVELOPMENT & LAUNCH電子煙質(zhì)量標準第7頁Electronic Cigarette Qu

18、ality Policies and Procedures Copyright JTI All production materials must be inspected before entering the production process to ensure that they meet specification.來料必須檢驗Batches of materials and components must be isolated on arrival and not removed from quarantine until compliance has been assured

19、.待檢物料必須隔離直到檢驗合格Inspection must be carried out according to documented procedures and results per batch retained.依據(jù)操作規(guī)程檢驗，并保持每批檢驗統(tǒng)計Responsibility for inspection is split according to material: 分兩類原材料E-liquids are released by JTI R&D QA and do not require detailed quality inspection by the e-cigarette

20、 manufacturer. 煙液由JTI提供，不需要制造商檢驗All other components are inspected and released by the e-cigarette manufacturer.其它需要制造商檢驗Incoming Material Inspection (IMI) General requirements84. PRODUCT MAINTENANCE電子煙質(zhì)量標準第8頁Electronic Cigarette Quality Policies and Procedures Copyright JTI General process基本過程E-liq

21、uid compounder produces a batch of E-liquid dedicated for JT Group products and sends representative samples to JTI R&D for batch release testing.JTI負責測試JTI R&D QA releases a batch of e-liquid for JT Group product and E-Liquid compounder ships it after receiving the QA release to the E-Cigarette man

22、ufacturer.測試后發(fā)貨給制造商E-cigarette manufacturer receives the batch, checks for any visual defects or undesirable odors.外觀檢驗，氣味檢驗If any deviations are noted, the batch should be quarantined and R&D QA contacted with full details for further action.發(fā)覺不良，隔離煙液，JTI處理Incoming Material Inspection (IMI) E-liqui

23、ds煙液檢驗94. PRODUCT MAINTENANCE電子煙質(zhì)量標準第9頁Electronic Cigarette Quality Policies and Procedures Copyright JTI General processIt is the responsibility of the E-cigarette manufacturer to design and implement IMI plans for all non-E-liquid components to assure that received materials comply with specificat

24、ions.檢驗標準有制造商自己依據(jù)JTI標準制訂On receipt of material batches, correct documentation should be assured, samples taken from the shipment and acceptance testing carried out according to documented procedures收料，抽樣，測試Documentation examples:文件舉例Supplier QC report 供給商QC匯報MSDSRoHS Declaration of Conformity，RoSH符合

25、性申明Battery safety test reports電池安全測試匯報Materials should not be allowed to enter production until satisfactory IMI results are observed檢驗合格方能上線Incoming Material Inspection (IMI) Non E-Liquid components非煙液原材料檢驗104. PRODUCT MAINTENANCE電子煙質(zhì)量標準第10頁Electronic Cigarette Quality Policies and Procedures Copyr

26、ight JTI Shelf life: maximum age of the component or finished good in which it can still be considered suitable for use in production or shipping to market保質(zhì)期就是原材料和產(chǎn)品適合生產(chǎn)和出貨General rule: materials/finished goods should be used in production or shipped to market as soon as possible after receipt or m

27、anufacture. Items exceeding shelf life should not be used in production or shipped to market. 基本標準：原材料盡快生產(chǎn)，成品盡快出貨，超出保質(zhì)期原材料和成品不能使用和出貨Date of production/receipt should be recorded for material batches and inventory control exercised to ensure first-in/first out (FIFO); the oldest material batches shou

28、ld be used first原材料生產(chǎn)日期和收貨日期要統(tǒng)計，先進先出Maximum shelf life of components should be as indicated by the supplier. Shelf life of finished goods should be no more than 12 months 原材料供給商要提供原材料保質(zhì)期，成品保質(zhì)期不得超出12個月 Shelf life of sealed e-liquid containers is 12 months from date of manufacture. Once containers are

29、 opened, the contents must be used within 30 days.密封煙液保質(zhì)期是12個月，煙液密封桶被打開后，必須在30天內(nèi)使用完Shelf life and storage policy保質(zhì)期和存放要求114. PRODUCT MAINTENANCE電子煙質(zhì)量標準第11頁Electronic Cigarette Quality Policies and Procedures Copyright JTI Adverse storage conditions (heat, light, humidity, mechanical stress) are a pr

30、ime driver for deterioration of quality 不利存放條件（熱，光，濕度，重壓）會造成不良E-liquid must be stored below 25C. Opened containers must be resealed as soon as practically possible after opening, and it is not permitted to return decanted e-liquid back into a master container. 煙液低于25度存放，開封煙液桶盡快重新封閉，不允許分出來煙液倒回大桶里Nico

31、tine-free e-liquid must be stored separately from nicotine-containing e-liquid.尼古丁和非尼古丁煙液必須分開儲存All other materials must be stored according to suppliers recommendations其它原材料按照供給商提議存放Finished product must be stored at 205C and 60 15% relative humidity成品必須在205C 和 60 15%條件下存放Shelf life and storage poli

32、cy124. PRODUCT MAINTENANCE電子煙質(zhì)量標準第12頁Electronic Cigarette Quality Policies and Procedures Copyright JTI Objective目標To ensure that finished goods meet JTI Product Quality Standards滿足JTI要求Process過程Following production of finished goods samples are taken for inspection抽檢The number of samples required i

33、s defined in ISO 2859-1, and is related to batch size and level of sampling (normal, reduced, tightened)依據(jù) ISO 2859-1Acceptability/unacceptability of the batch is determined by the number of defects observed during inspection接收是否決定于檢驗出不良數(shù)目E-cigarette manufacturer is responsible for physical, electri

34、cal, functional and visual testing制造商負責物理化學功效和外觀察試Finished goods inspection General process成品檢驗-基本步驟135. PRODUCT MONITORING電子煙質(zhì)量標準第13頁Electronic Cigarette Quality Policies and Procedures Copyright JTI Sampling is initiated as normal inspection for the first inspected lot.第一批成品作為normal（正常）來檢驗Switchin

35、g to reduced or tightened inspection should be carried out once the criteria given in Section 9 of ISO 2859-1 are met.ISO2859-1第九章符合后切換到reduced（降低）或者tighten（加嚴）檢驗Reduced inspection can be introduced after multiple inspected lots which would have been accepted at a lower AQL.Reduced（降低）檢驗要在多批次檢驗合格后才能

36、導入Tightened inspection must be introduced if 2/5 consecutive lots are deemed unacceptable on first inspection.連續(xù)5批中有2批不合格就要導入加嚴檢驗Finished goods inspection Sampling scheme145. PRODUCT MONITORING電子煙質(zhì)量標準第14頁Electronic Cigarette Quality Policies and Procedures Copyright JTI E-Cigarette manufacturer is r

37、equested to provide representative samples of each product manufactured during a production month to JTI R&D QA.每個月送樣給JTI研發(fā)質(zhì)量部JTI R&D QA will clearly indicate the required products, quantities and shipping address to the E-Cigarette manufacturer.JTI會通知機種，數(shù)量和到達地址E-cigarette manufacturer will arrange

38、shipping by the most expeditious means (normally air freight) with all required shipping documentation.制造商準備好快捷貨運（普通是空運），隨貨備好裝運文件JTI R&D QA will be informed of dispatch and shipment tracking information by E-cigarette manufacture.通知JTI貨運信息155. PRODUCT MONITORINGMonthly Sample Submission月度送樣電子煙質(zhì)量標準第1

39、5頁Electronic Cigarette Quality Policies and Procedures Copyright JTI Objective 目標To prepare the manufacturing process for a new production in a controlled manner控制生產(chǎn)過程Benefits 好處Eliminate potential for wrong material usage, incorrect assembly or product contamination預防錯料，不正確裝配和生產(chǎn)污染Process過程Remove al

40、l materials from previous production from shop floor去除全部上次生產(chǎn)物料Clean machinery as necessary有必要時候清潔機器Check materials for new production according to specification檢驗原材料規(guī)格Prepare work instructions for new production準備好作業(yè)指導書Setup machinery and production line準備好機器和生產(chǎn)線Changeover procedure166. PROCESS CONT

41、ROL電子煙質(zhì)量標準第16頁Electronic Cigarette Quality Policies and Procedures Copyright JTI Process (continued)過程Calibrate measurement equipment校準測試設(shè)備Start production line, perform start-up inspection開線，開線檢驗Commence full production when required specifications within tolerances are observed開線檢驗合格開始生產(chǎn)Changeover

42、 procedure換線程序176. PROCESS CONTROL電子煙質(zhì)量標準第17頁Electronic Cigarette Quality Policies and Procedures Copyright JTI The Manufacturing Quality Plan (MQP) is a detailed document covering the measurement plans and process control guidelines necessary to deliver product conforming to JTI standards生產(chǎn)質(zhì)量控制計劃涵蓋

43、測試計劃和過程管控以到達JTI標準The MQP should be designed and implemented by the E-cigarette manufacturer制造商負責制訂和實施生產(chǎn)質(zhì)量控制計劃IPC-A-610D (level 2) must be incorporated into the MQP and followed during the manufacturing processIPC-A-610D（第二等級）必須包含進生產(chǎn)質(zhì)量控制計劃MQP must be shared and aligned with JTI R&D QA, and any subseq

44、uent changes shared in advance.MQP要與JTI共享并保持標準一致Full records of inspections made according to the MQP must be made and retained for 5 years.檢驗全部統(tǒng)計必須保留5年。Manufacturing Quality Plan生產(chǎn)質(zhì)量控制計劃186. PROCESS CONTROL電子煙質(zhì)量標準第18頁Electronic Cigarette Quality Policies and Procedures Copyright JTI QUIP covers the

45、 process of Quality Unsure finished product inspection. It is activated when product not conforming to specifications or failing to meet quality criteria is observed.QUIP涵蓋品質(zhì)不確定成品檢驗，當成品不符合規(guī)格時開啟QUIPBenefits好處Ensures defective product is not shipped確保不良品沒有出貨Clear guideline for effective and efficient

46、decision making清楚規(guī)范來做出高效決定E-cigarette manufacturer is responsible for following guidelines and setting and maintaining factory non-conforming/blocking procedures制造商負責設(shè)定和維護工廠不合格品管理Action taken is related to defect level依據(jù)不良等級來采取辦法QUIP Procedure196. PROCESS CONTROL電子煙質(zhì)量標準第19頁Electronic Cigarette Quali

47、ty Policies and Procedures Copyright JTI D Class defects require stopping the production line, taking immediate corrective action and carrying out 100% inspection to the last good check.D類不良要求停線，立刻采取辦法，100%全檢直到檢驗到上一批次完全合格For B or C class defects, product should be resampled and rechecked to confirm

48、the issueB，C類不良，產(chǎn)品應該重新抽樣確定不良B Class: Management verify if defect is consumer-noticeable. If yes, shut down production line, fix problem and sample/inspect case by case back to the last good check.B類不良，管理層檢驗是否是客戶能夠覺察到不良，假如是，停線，處理問題，抽樣檢驗直到上一批次完全合格C class: Shut down production line, fix problem and sam

49、ple/inspect case by case back to the last good check.C類不良，停線，處理問題，抽樣檢驗直到上一批次完全合格The QUIP event should be recorded and details sent to JTI R&D QA QUIP事件應該被統(tǒng)計并發(fā)給JTI研發(fā)質(zhì)量部QUIP Procedure206. PROCESS CONTROL電子煙質(zhì)量標準第20頁Electronic Cigarette Quality Policies and Procedures Copyright JTI Correct hygiene manag

50、ement is essential to mitigate the risk of foreign matter contamination衛(wèi)生管理有利于降低外來物質(zhì)污染 E-cigarette manufacturer should:制造商應該Ensure state-of-the-art sanitation management確保最新要求衛(wèi)生管理Implement and maintain a foreign matter control program實施外來污染管理程序Maintain documented procedures and inspection records維護程

51、序保持檢驗統(tǒng)計Examples:例子Uniform (cap, coat, gloves, mask)服裝（帽子，外套，手套，口罩）Standardised cleaning and inspection標準化清潔和檢驗Standardised building maintenance標準化廠房維護Clearly organised workstations with no unnecessary materials整齊有序工作臺，沒有雜物Hygiene Management衛(wèi)生管理217. QUALITY MANAGEMENT電子煙質(zhì)量標準第21頁Electronic Cigarette Q

52、uality Policies and Procedures Copyright JTI Standard process for dealing with communication expressing dissatisfaction with product quality標準處理流程JTI collect, categorise and evaluate complaints from consumers JTI搜集，分類和評定客戶埋怨Divided into Routine and Special complaints分成普通和嚴重客戶埋怨Routine: product perfo

53、rmance, normal visual quality defects普通：產(chǎn)品性能，普通外觀不良Special: Health/legal related complaints 嚴重：健康和法律相關(guān)埋怨Details of manufacturing-related complaints are communicated to e-cigarette manufacturer for further action詳細信息會通知到制造商Consumer Complaints客戶埋怨227. QUALITY MANAGEMENT電子煙質(zhì)量標準第22頁Electronic Cigarette

54、Quality Policies and Procedures Copyright JTI E-cigarette manufacturer is responsible for:制造商負責Corrective/preventative action for complaints related to manufacturing process糾正和預防辦法實施在生產(chǎn)過程Timely reports and feedback to R&D QA及時匯報給JTI研發(fā)品質(zhì)部Continuous improvement of manufacturing quality連續(xù)改進生產(chǎn)過程質(zhì)量Reimbu

55、rsement or replacement of defected devices to JTI賠償或者換貨Consumer Complaints客戶埋怨237. QUALITY MANAGEMENT電子煙質(zhì)量標準第23頁Electronic Cigarette Quality Policies and Procedures Copyright JTI Serious Quality Incidents cover:嚴重質(zhì)量事故包含Health and safety related risks (actual or potential consumer injury)健康和安全相關(guān)風險（發(fā)生

56、和潛在對消費者傷害）Corporate risks (product not registered for sale, confidential product shipped)企業(yè)風險（產(chǎn)品沒注冊，保密產(chǎn)品出貨）Contamination/Foreign Matter 污染和外部物質(zhì)摻入Serious Manufacturing Defects嚴重產(chǎn)品不良In case of Serious Quality Incident in market, JTI R&D QA will inform e-cigarette manufacturer for immediate investigati

57、on and action一旦發(fā)生嚴重質(zhì)量事故，JTI要求制造商立刻調(diào)查Serious Quality Incident Management247. QUALITY MANAGEMENT電子煙質(zhì)量標準第24頁Electronic Cigarette Quality Policies and Procedures Copyright JTI E-cigarette manufacturer is responsible for:制造商負責Corrective/preventative action as highest priority糾正和預防辦法當做最主要事情來做Report and fe

58、edback to JTI R&D QA as soon as it is practically possible一旦發(fā)生馬上通知JTI研發(fā)質(zhì)量部Reimbursement or replacement of defected devices to JTI賠償或者換貨In case E-cigarette manufacturers internal investigations indicate the possibility for a Serious Quality Incident, they should proactively inform JTI R&D QA with details and the range of products which may be affected制造商內(nèi)部調(diào)查內(nèi)容及影響到產(chǎn)品范圍需要主動通知JTI研發(fā)品質(zhì)部Serious Quality Incident Management嚴重質(zhì)量事故管理257. QUALITY MANAGEMENT電子煙質(zhì)量標準第25頁Electronic Cigarette Quality Polic